NCT02253524已完成4 期
Comparison of Efficacy Dimenhydrinate and Metoclopramide in the Treatment of Nausea Due to Vertigo
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- compare the effects of intravenous dimenhydrinate and metoclopramide in the treatment of nausea due to vertigo in emergency setting. (nausea and vertigo scores as measured by Visual Analogue Scale.)
研究概览
简要总结
- Vertigo complaint is one of the common cause of patients who applied to emergency services.
- Patients who have applied to emergency services with vertigo complaint mostly have nausea as an additionally symptom to this complaint and anti-emetic agents can be used in their treatments very often.
- The investigators purpose is to investigate the advantages of Dimenhydrinate and metoclopramide to each other in the treatment of vertigo and the vertigo accompanied by nausea
详细描述
- Vertigo describes the illusion of being subject to an involuntary movement, usually rotational, of the patient or the patient's surroundings which is caused by sudden tonic neural activity.
- The management and episodic treatment of patients with spontaneous vertigo related nausea-vomiting symptoms are somewhat controversial in the emergency department setting.
- Patients admitted to the emergency department with complaints of vertigo in addition to a large portion of the symptoms are accompanied by nausea and antiemetic agents are frequently used in the treatment.
- An ideal treatment should be rapid in onset and effective, and lack debilitating side effects.
- Although a wide variety of classes of pharmacologic agents and modalities are used, the emergency department treatment of acute spontaneous vertigo and associated with nausea- vomiting has not been well studied.
- It has been reported that the most commonly used medications for parenteral treatment of vertigo and nausea-vomiting in emergency department are dimenhydrinate (DMT) and metoclopramide (MTP).
- It has a depressant action on hyper-stimulated labyrinthine function and antiemetic effects, believed to be due to the antihistamine.
- Dimenhydrinate inhibits vomiting by affecting the histaminic receptor and cholinergic receptor function center of vestibular nucleus in the central vestibular system.
- Dimenhydrinate reduces the symptoms of vertigo with depressant effects on the labyrinth function by this means.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 to 65 years old patients,
- •had vertigo and accompanied nausea or vomiting [VAS (visual analog scale) score >5] during their emergency department episode of care for which the attending physician recommended intravenous antiemetic medication.
排除标准
- •abnormal vital signs,
- •women who were pregnant or lactation,
- •those with a history of epilepsy,
- •acute psychiatric symptoms,
- •organic brain disease,
- •parkinson's disease or phaeochromocytoma,
- •or any known allergy to the study drugs,
- •uncooperative individuals,
- •use of any antiemetic drug in the previous 8 hours or previous delivery of intravenous fluids during the emergency department episode of care,
- •currently undergoing chemotherapy or radiotherapy,
- •mechanical obstruction or perforation,
- •gastrointestinal bleeding,
- •inability to understand study explanation or outcome measures (any reason),
- •known allergy or previous adverse reaction to metoclopramide or dimenhydrinate,
- •and patients who refused to participate study.
研究组 & 干预措施
Dimenhydrinate
Active Comparator
50 mg Dimenhydrinate with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
干预措施: Dimenhydrinate (Drug)
Metoclopramide
Active Comparator
10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
干预措施: Metoclopramide (Drug)
结局指标
主要结局
compare the effects of intravenous dimenhydrinate and metoclopramide in the treatment of nausea due to vertigo in emergency setting. (nausea and vertigo scores as measured by Visual Analogue Scale.)
时间窗: Change from Baseline in nausea and vertigo scores at 30 minutes.
- participants will be followed for the duration of hospital stay, an expected average of 30 minutes.
次要结局
未报告次要终点
研究者
Bulent Erdur
Assoc. Prof.
Pamukkale University
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